Once-daily Fluticasone Furoate∗ Nasal Spray (FF) Provides 24-hour Symptom Relief In Subjects With Seasonal Allergic Rhinitis (SAR) Caused By Mountain Cedar Pollen ∗USAN approved name

Abstract

RATIONALE: FF is a novel enhanced-affinity steroid being developed for the treatment of rhinitis.METHODS: Three hundred two subjects (≥12 years) with active SAR to mountain cedar pollen were randomized to once-daily FF 110mcg or placebo spray administered in a unique, side-actuated device. Primary endpoint: Mean change from baseline (MCFB) over the entire 2-week treatment period in daily reflective total nasal symptoms scores (rTNSS), which was the sum of 4 symptoms: nasal congestion, itching, rhinorrhea, and sneezing. Key secondary endpoints were MCFB in AM pre-dose instantaneous total nasal symptoms scores (iTNSS), overall response to therapy (ORT), and MCFB in daily reflective total ocular symptoms scores (rTOSS). Total ocular scores were the sum of 3 symptoms: eye itching/burning; tearing/watering; and redness. Nasal and ocular symptom data were analyzed using ANCOVA. ORT was analyzed using logistic regression.RESULTS: For the primary endpoint, MCFB in rTNSS, FF 110mcg was significantly more effective at improving the nasal symptoms of SAR compared with placebo (p = 0.003). FF 110mcg also was significantly more effective for the key secondary endpoints: MCFB in AM pre-dose iTNSS (p <0.001), ORT (p <0.001), and MCFB in rTOSS (p =0.008). The incidence of epistaxis was 7% and 5% in the placebo and FF groups, respectively, but in each group, only 3% were considered drug-related. There were no serious AEs.CONCLUSIONS: The results of this study support the use of once-daily FF 110 mcg for the symptoms of seasonal allergic rhinitis caused by mountain cedar pollen in subjects 12 years of age and older. RATIONALE: FF is a novel enhanced-affinity steroid being developed for the treatment of rhinitis. METHODS: Three hundred two subjects (≥12 years) with active SAR to mountain cedar pollen were randomized to once-daily FF 110mcg or placebo spray administered in a unique, side-actuated device. Primary endpoint: Mean change from baseline (MCFB) over the entire 2-week treatment period in daily reflective total nasal symptoms scores (rTNSS), which was the sum of 4 symptoms: nasal congestion, itching, rhinorrhea, and sneezing. Key secondary endpoints were MCFB in AM pre-dose instantaneous total nasal symptoms scores (iTNSS), overall response to therapy (ORT), and MCFB in daily reflective total ocular symptoms scores (rTOSS). Total ocular scores were the sum of 3 symptoms: eye itching/burning; tearing/watering; and redness. Nasal and ocular symptom data were analyzed using ANCOVA. ORT was analyzed using logistic regression. RESULTS: For the primary endpoint, MCFB in rTNSS, FF 110mcg was significantly more effective at improving the nasal symptoms of SAR compared with placebo (p = 0.003). FF 110mcg also was significantly more effective for the key secondary endpoints: MCFB in AM pre-dose iTNSS (p <0.001), ORT (p <0.001), and MCFB in rTOSS (p =0.008). The incidence of epistaxis was 7% and 5% in the placebo and FF groups, respectively, but in each group, only 3% were considered drug-related. There were no serious AEs. CONCLUSIONS: The results of this study support the use of once-daily FF 110 mcg for the symptoms of seasonal allergic rhinitis caused by mountain cedar pollen in subjects 12 years of age and older.